Bi-layer orthotic

ABSTRACT

A bi-layer orthotic having an orthotic portion and a base layer is provided. The orthotic portion is operably coupled at a heel thereof to the base layer by a coupling. The coupling may comprise an off axis rotator axel or an arcuate rotator follower. The bi-layer orthotic is configured to provide therapeutic correction to a pronated or supinated foot.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/827,949, filed on Mar. 14, 2013 (allowed); which claims the benefitof priority to U.S. provisional application Ser. No. 61/707,344, filedon Sep. 28, 2012; and which claims the benefit of priority to U.S.provisional application Ser. No. 61/665,097, filed on Jun. 27, 2012; theentireties of which are incorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates generally to orthotics and moreparticularly to a bi-layer orthotic and a tri-layer orthotic configuredto absorb energy and then return it to an individual wearer's foot.

BACKGROUND OF THE RELATED ART

Walking and running can be defined as methods of locomotion involvingthe use of the two legs, alternately, to provide both support andpropulsion, with at least one foot being in contact with the ground atall times. While the terms gait and walking are often usedinterchangeably, the word gait refers to the manner or style of walking,rather than the actual walking process. The gait cycle is the timeinterval between the exact same repetitive events of walking.

The defined cycle can start at any moment, but it typically begins whenone foot contacts the ground and ends when that foot contacts the groundagain. If it starts with the right foot contacting the ground, then thecycle ends when the right foot makes contact again. Thus, each cyclebegins at initial contact with a stance phase and proceeds through aswing phase until the cycle ends with the limb's next initial contact.Stance phase accounts for approximately 60 percent, and swing phase forapproximately 40 percent, of a single gait cycle.

Hard surfaces in modern human environments have changed the forcesencountered by the human musculoskeletal system during the gait cycle ascompared to the forces which it evolved to sustain. Impact energies fromsuch surfaces enter the body through boney and dense tissues and throughsoft and fatty tissues. Such impact energy frequently causes physicaldamage leading to injury, in particular injury of the foot. At times,this type of physical injury can be treated by an orthotic insert.

Functional orthotic inserts may be placed in a shoe either on top of orin place of the insole to correct foot alignment and side-to-sidemovement during standing, walking, running to influence the orientationof the bones in a human foot and to influence the direction and force ofmotion of the foot or parts of the foot. Orthotics thereby decreasepain, not only in the foot, but also in other parts of the body such asthe knee, hip and lower back. They can also increase stability in anunstable joint and prevent a deformed foot from developing additionalproblems. However, conventional devices are not dynamic as designed.Conventional orthotic devices typically include a shimmed, rigid postand as a result dynamic adjustments to the foot during the gait cyclecannot be done. For example, adjustments such as making the foot tip outfurther, making the foot tip in further, raising the heel, raising theball of the foot, and the like cannot be accomplished with conventionaldevices dynamically during the gait cycle.

Other causes of injury to the foot relate to underlying pathologicaldisease states, such as by way of example, diabetes. Diabetes is achronic disease that affects up to six percent of the population in theU.S. and is associated with progressive disease of the microvasculature.Complications from diabetes include not only heart disease, stroke, highblood pressure, diabetic retinopathy but also in particular diabeticneuropathic foot disease.

Diabetic neuropathic foot disease typically results in the formation ofulcers which commonly result from a break in the barrier between thedermis of the skin and the subcutaneous fat that cushions the footduring ambulation. This rupture may lead to increase pressure on thedermis. While there are devices and methods that purport to preventplanar ulcer formation in a diabetic patient there are no orthoticdevices on the market that treat the ulcer with dynamic offloading afterformation.

Other types of injury to the foot include fractures, pressure sores,surgical sites and overuse injuries. Patho-mechanical foot dysfunctionsinclude supination and pronation pathologies.

Therefore, what is needed is a orthotic system that can be usedremedially to correct deformities resulting from physical and otherinjuries to the foot. What is also needed is a dynamic orthotic systemthat can be used therapeutically to address underlying pathologies andpatho-mechanical foot dysfunctions to accurately and precisely positionthe foot throughout the gait cycle in order to promote proper functionand alignment and mitigate excessive forces.

BRIEF SUMMARY OF THE INVENTION

The aforementioned problems are addressed by the orthotic system inaccordance with the present invention. In one aspect of the presentinvention, the system broadly includes a base layer; a platen; anorthotic and a lever operably coupling the base layer through a pass inthe platen. The foregoing elements work together as a system to absorbenergy in walking, running and the like and return it to the foot at theproper time and location. The orthotic may comprise a segmented orthoticor a non-segmented orthotic. The lever may include a slide portion and adraw pin or tensioning member that is anchored to the orthotic throughthe pass in the platen. The orthotic energy system in accordance withthe invention controls the energy produced from the gait cycle to deformthe orthotic layer in a particular location or in a particularangulation to supinate or pronate the foot. The system may also beadapted to address a variety of orthopedic remedial and therapeuticissues.

Also disclosed is a bi-layer orthotic that therapeutically addressespronation and supination issues in a patent.

Also disclosed is an air-heel that is a bi-layer orthotic adapted to becosmetically incorporated in women's shoes that promote proper functionand alignment and mitigate excessive forces.

Also disclosed is an orthotic that includes a kick stand that movesmedially or laterally to correct supination or pronation.

Those of skill in the art will appreciate that the orthotic systemsdisclosed herein have broad applications and may be incorporated intodiabetic shoes; sports or athletic shoes; every day footwear includingwomen's shoes, boots and the like whether a remedial or therapeuticresult is desired without departing form the scope or spirit of theinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

For a better understanding of the invention, and to show how the samemay be carried into effect, reference will now be made, by way ofexample, to the accompanying drawings, in which:

FIG. 1 is a side elevational view of the orthotic energy return systemin accordance with the invention with foot shown in phantom dashedlines.

FIG. 2 is a view thereof wherein the subject has initiated the gaitcycle.

FIG. 3 is a view thereof wherein the foot has advanced in the gait cycleto initial contact with the ground or heel strike.

FIG. 4 is a view thereof rebounding from initial contact or heel strikeat mid-stance.

FIG. 5 is a view thereof showing terminal stance with arrow movingtoward toe-off or pre-swing phase.

FIG. 6 is a view of the tri-layer orthotic in accordance with theinvention showing various attachment points for tensioning member andthe effects thereof.

FIG. 7 is a side elevational view of a first alternative embodiment ofthe invention at the commencement of the gait cycle.

FIG. 8 is a view thereof at heel strike.

FIG. 9 is a view thereof rebounding from heel strike and moving towardmid-stance.

FIG. 10 is a view thereof at terminal stance with foot moving towardtoe-off or the pre-swing phase.

FIG. 11 is a side elevational view of a second alternate embodiment ofthe invention beginning initial contact with the ground.

FIG. 12 is a view thereof at full initial contact with the ground.

FIG. 13 is a view thereof at mid-stance with arrow showing footadvancing toward terminal stance.

FIG. 14 is a view thereof near pre-swing.

FIG. 15 is a side elevational view of a third alternate embodiment ofthe invention shown on an equines patient in the unburdened position.

FIG. 16 is a view thereof in a position toward loading.

FIG. 17 is a view thereof at toe impact.

FIG. 18 is a view thereof at completion of toe impact.

FIG. 19 is a side elevational view of a fourth alternate embodiment ofthe invention with the foot depicted in a static unburdened position.

FIG. 20 is a side elevational view of a fifth alternate embodiment ofthe invention shown in a static unburdened position.

FIG. 21 is an enlarged detail taken from the area 21A of FIG. 20.

FIG. 22 is a side elevational view of a sixth alternate embodiment ofthe invention in a static position showing the secondary position ofselected elements.

FIG. 23 is a side elevational view of a seventh alternate embodiment ofthe invention showing the secondary position of selected elements.

FIG. 24 is top plan view of an exemplary embodiment of an orthotic inaccordance with the invention.

FIG. 25 is a side elevational view taken along line 25-25 of FIG. 24showing a secondary position.

FIG. 26 is a front elevational view thereof showing the secondaryposition.

FIG. 27 is a top plan view of a first variation of the subject of FIG.24 wherein the orthotic is segmented laterally.

FIG. 28 is a front elevational view thereof showing a secondary positionand the angle of correction.

FIG. 29 is a top plan view of a second variation of the subject of FIG.24 wherein the orthotic is segmented medially.

FIG. 30 is a front elevational view thereof showing a secondary positionand the angle of correction.

FIG. 31 is a top plan view of an exemplary embodiment of a orthotic inaccordance with the invention having all rays segmented.

FIG. 32 is a side elevational view thereof similar to that of FIG. 25showing a secondary position.

FIG. 33 is a front elevational view thereof showing the secondaryposition.

FIG. 34 is a side elevational view of a bi-layer orthotic in accordancewith an embodiment of the invention with parts omitted for clarity.

FIG. 35 is a rear elevational view of the bi-layer orthotic of FIG. 34taken along line 35-35 and showing a pronated foot requiring correctiondescending into the bi-layer orthotic.

FIG. 36 is a rear elevational view thereof showing the therapeuticcorrection of a pronated foot.

FIG. 37 depicts a supinated foot descending into the bi-layer orthoticin accordance with the invention of FIG. 34 and showing the correction.

FIG. 38 is a side elevational view of a first alternative bi-layerorthotic embodiment in accordance with the invention with parts omittedfor clarity.

FIG. 38A is an enlarged fragmentary pictorial detail taken from the area38A of FIG. 38 the bi-layer orthotic of FIG. 38.

FIG. 39 is a rear elevational view of the orthotic of FIG. 38 takenalong line 39-39 and showing a supinated foot requiring correctiondescending into the orthotic.

FIG. 40 is a rear elevational view thereof showing the therapeuticcorrection using the bi-layer orthotic of FIG. 39 in accordance with theinvention.

FIG. 41 is a rear elevational view similar to that of FIGS. 39 and 40showing the correction of a pronated foot using the bi-layer orthotic ofFIG. 38 in accordance with the invention.

FIG. 42 is a rear elevational view of a second alternative embodiment ofa bi-layer orthotic similar to that of FIG. 38 but including two arcuatechannels and showing a pronated foot descending downward into theorthotic.

FIG. 43 is a view similar to that of FIG. 42 showing the correction ofthe pronated foot.

FIG. 44 is similar to the embodiment of FIGS. 42 and 43 wherein asupinated foot is shown descending and then having been corrected by thebi-layer orthotic of FIG. 42 in accordance with the invention.

FIG. 45 is a side elevational view of a third alternative embodiment ofa bi-layer orthotic in accordance with the invention with parts omittedfor clarity.

FIG. 46 is a rear elevational view thereof.

FIG. 47 is a front elevational view thereof.

FIG. 48 is a bottom plan view thereof.

FIG. 49 is a bottom plan view of a first alternative embodiment of thebi-layer orthotic of

FIGS. 45-48 in accordance with the invention.

FIG. 50 is a bottom plan view of a second alternative embodiment of thebi-layer orthotic of FIGS. 45-48 in accordance with the invention.

FIG. 51 is a bottom plan view of a third alternative embodiment of thebi-layer orthotic of FIGS. 45-48 in accordance with the invention.

FIG. 52 is a bottom plan view of a fourth alternate embodiment of thebi-layer orthotic of

FIGS. 45-48 in accordance with the invention.

FIG. 53 is a top plan view of an alternative embodiment of an orthoticin accordance with the invention showing a kick stand strut.

FIG. 54 is a rear view of a supinated foot showing the kick stand strutdeployed.

FIG. 55 is an alternative embodiment of a bi-layer orthotic inaccordance with the invention.

FIG. 56 is a fragmentary side elevational detail view of the part of theembodiment of FIG. 55.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to FIGS. 1 through 6, a first embodiment of the orthoticenergy return system in accordance with the invention is depicted. FIG.1 illustrates a foot (in phantom lines) at rest wearing the energyreturn system 10 in accordance with the invention. The energy returnsystem 10 is shown in the unburdened or off-loaded position with thebase layer 12 at rest on a surface such as the ground. The energy returnsystem 10 broadly includes base layer 12, lever 14, platen 16 andorthotic 18. Base 12 may be of any length so long as it generallyextends from the sole of the foot to the toe region. Base 12 maycomprise any material used for the soles of shoes including but notlimited to rubber, plastics, polymers, polyurethanes and the like. Lever14 includes slide 22, angled central portion 24 and angled connectingportion 26. Lever 14 is made from a material that is resilient to allowit to dynamically deform during the gait cycle. Suitable materials thatmay be utilized for lever 14 include plastics, polymers and resilientmetals. Orthotic 18 is also made from a material that is resilient toallow it to dynamically deform during the gait cycle. Suitable materialsthat may be utilized to construct orthotic 18 include polyolefin;polypropylene, open and closed cell foams and graphites. Platen 16 isdesirably made from rigid or semi-rigid materials such as plastics knownto those of skill in the art.

Tensioning member 28 operably couples lever 14 at angled connectingportion 26 to orthotic 18. Tensioning member 28 is depicted as a pinhowever those of skill in the art will appreciate that rods, cables,wires, filaments and the like may be substituted for pin 28. Platen 16may be substantially rigid and is operably coupled to orthotic 18,through heel cup 20, by connecting member 30. Connecting member 30 maycomprise pins, rods, wires, filaments and the like. Those of skill inthe art will appreciate that connecting member 30 may be eliminated andplaten 16 may be indirectly coupled to orthotic 18 by adhesive means orchemical bonding between platen 16 and heel cup 20 and between heel cup20 and orthotic 18.

The energy return system in accordance with the invention will now bedescribed in operation. Referring now to FIGS. 2-5 the gait cycle andthe operation of the energy return system is illustrated. Thus, anunderstanding of the gait cycle is helpful to the understanding of theoperation of the energy return system in accordance with the invention.

The gait cycle begins when one foot contacts the ground and ends whenthat foot contacts the ground again. Thus, each cycle begins at initialcontact with a stance phase and proceeds through a swing phase until thecycle ends with the limb's next initial contact. There are two phases ofthe gait cycle. Stance phase is the part of the cycle when the primaryfoot is in contact with the ground and begins with initial contact orheel strike and ends with toe-off. Swing phase occurs when the opposite,second foot is in the air and begins with toe-off and ends with thesecond heel strike.

Referring now to FIG. 2, the loading response begins with initialcontact, the instant the primary foot contacts the ground. In a normalgait pattern, the heel of the primary foot contacts the ground first(unless the patient has equines as depicted in alternative embodiment inFIGS. 5-6). The downward force (DF) of the heel causes base layer 12 todeform upwardly toward the heel as noted by arrow U. Angled centralportion 24 of lever 14 commences to compress downwardly 37 toward slide22 as angled connecting portion rotates distally RB toward angledcentral portion 14 causing the buildup of tension on tensioning member28. Because angled connecting portion 26 is operably coupled to orthotic18 by tensioning member 28 the tensioning of tensioning member causesthe orthotic to deform downwardly. These motions collectively cause theenergy return system in accordance with the invention to load.

Referring now to FIG. 3 the downward force of the heel continues tocause base 12 to deform upwardly U toward platen 16. Particularly,angled central portion 24 of lever 14 deforms closer to slide 22 asconnecting portion 26 rotates distally RB loading tension member 18 withtension. Tensioning member 18 causes orthotic to continue to movedownwardly OD. As can be seen, the arch of the foot is compressed downfurther than as seen in FIG. 2 and thus more energy is being stored inthe orthotic layer 18.

Loading response ends with contralateral toe off, when the opposite,second foot leaves the ground (not shown). Midstance begins withcontralateral toe off and ends when the center of gravity is directlyover the reference foot as seen in FIG. 4. This phase, and earlyterminal stance, are the only times in the gait cycle when the body'scenter of gravity truly lies over the base of support. Terminal stancebegins when the center of gravity is over the supporting foot and endswhen the contralateral foot contacts the ground. During terminal stance,the heel rises from the ground.

Referring now to FIG. 4 the foot is shown at mid-stance as it commencesto rotate forward and energy stored in the orthotic 18 combined with theprevious deformation of the base 12 begins a rebound effect to the footalong the arch. Slide 22 releases partially from base 12 as angledconnecting member 26 rotates forwardly F thus starting to release thetension of tensioning member 28 on orthotic 18.

Pre-swing begins at contralateral initial contact and ends at toe off,at around 60 percent of the gait cycle. Thus, pre-swing corresponds tothe gait cycle's second period of double limb support. Initial swingbegins at toe off and continues until maximum knee flexion (60 degrees)Occurs.

Referring now to FIG. 5 the primary foot is shown at terminal stancemoving toward toe-off. In toe-off the foot continues its forwardrotation FR and energy stored in the orthotic 18 combined with the base12 completes the rebounding of energy to the foot along the arch.Downward tension is completely off-loaded from tensioning member 28 andin turn orthotic 18. However, due to the storage of energy in orthotic18, orthotic 18 presses upwardly UP against arch causing the arch torise until it reaches the position should in FIG. 1.

Referring again to FIGS. 2-5, the heel strike and the deceleration ofthe body mass as it impacts the ground will deforms the base 12, flexingit up in the rear, which will then cause lever 14 to lever off theplaten 16 and tension the tensioning member 28 which in turn deformsorthotic 18 due to the coupling thereof with tensioning member 28.Orthotic 18 may be coupled in the back (as best seen in FIGS. 2-5) toallow for the tensioning member 18 to dynamically pull the front of theorthotic 18 back towards the fixed point in the rear 34.

Alternatively, orthotic 18 may be operably coupled to platen 16 at afixed point in the front (as best seen in FIG. 22). If orthotic 18 isfixed at a front point to platen 16 the leverage from flexion of thefront of the sole as it bends up would in turn leverage tensioningmember 28 and pull the heel portion of the orthotic 18 forward resultingin the base 12 storing energy.

Thus, the constraint of the base 12 is not controlled; rather it isdynamic in that the stored energy is readily disbursable. The base layer12 is not just deflecting the lever. It also absorbs energy and providesshock absorption at heel strike. The stored energy has a tendency to bedestabilizing. Thus, the energy return system in accordance with theinvention controls the energy to deform the orthotic 18 in such a waythat the treatment of particular foot pathologies is possible. Inaddition, the energy return system is capable of releasing the energylater in the gait cycle by adjusting the location of the lever front toback and by reversing its direction and/or by lengthening the orthoticto perform a particular function.

For example, if one desires to offload an area of excessive pressuresuch as a diabetic ulcer or a non-union of a fracture (that cannot beloaded when a person is walking otherwise it will cause the fracture tomove), the orthotic can be segmented at the front portion (as best seenin alternative embodiment depicted in FIG. 31). Thus, the tensioningmember may be manipulated to deform the orthotic at a particularlocation/segment or in a particular angulation. Alternatively, the archcan be raised to supinate the foot. Still alternatively, if there is alateral attachment point the foot can be pronated by drawing up thelateral side of the orthotic thus being able to dynamically generate asupination or pronation moment or force while the person is walking.

Further, if the attachment point of the tensioning member 28 to theorthotic 18 was substantially at the middle of the arch the tensioningmember 28 would drive the orthotic 18 down and flatten it.Alternatively, if the attachment point of the tensioning member 28 tothe orthotic 18 was towards the front of the orthotic 18 the tensioningmember 28 would draw the orthotic 18 back and raise the arch. Criticalto understanding the forgoing is that the ball of the foot is drawn downinto a position closer to contact on the platen, i.e. the plane ofsupport, causing the arch of the foot to carry weight bearing pressureand not the ball of the foot during mid-stance (as seen best in FIG.13).

Referring again to FIG. 3, it depicts further compression of the energyreturn system. Thus, the arch of the foot is seen as compresseddownwardly even further (than in FIG. 2) and thus more energy is beingstored in the orthotic 18. If pathology exists in the forefoot, by wayof example an ulcer or a stress fracture or a metatarsal non-union, whenthe orthotic 18 is once again allowed to elevate, it creates an upwardmoment or force behind the ball of the foot that will lift and unloadthe ball as the person is moving toward forefoot loading in which theball of the foot sustains a great deal of pressure. The lift createdright behind the ball of the foot will unload or unweight. FIGS. 1-5depict a basic energy return system. A lever operably coupled at thefront of the orthotic and a lever operably coupled to a back portion ofthe orthotic have been described. As lever deforms the orthotic layeralso deforms. How it deforms, i.e. in which direction and at whatangulation, depends primarily in part on the point of attachment oflever 14 as will now be discussed in detail.

Referring now to FIG. 6 various attachment points on tensioning member28 and resulting actions are depicted. If the attachment point of thetensioning member 28 to the orthotic 18 is varied, such variation willcause the orthotic 18 to flex in different ways to affect the foot. Witha rear attachment of tensioning member 28 to orthotic, the arch of theorthotic 18 is lowered thus reducing ground reactive force between thefoot and the orthotic that in the case of posterior tibial dysfunctionmay make the orthotic intolerable to the patient. This dynamic loweringof ground reactive forces at impact may allow greater biomechanicalcontrol to be tolerated by the patient. If the attachment point of thetensioning member 14 to the orthotic 18 is at the front of the orthotic18, the orthotic arch is raised as best seen in FIG. 13.

In human anatomy, the subtalar joint occurs at the meeting point of thetalus and the calcaneus. The subtalar joint allows inversion andeversion of the foot during the gait cycle. Thus, depending on what footpathology needed treatment, the attachment point of the tensioningmember would affection the function of the energy return system. If theattachment point of the tensioning member is placed lateral to thesubtalar joint access toward the fifth ray or the lateral aspect of theforefoot, it would have the effect of raising the lateral arch of theorthotic to pronate the foot or tip the foot inward and cause eversionof the subtalar joint. Attachment of the tensioning member medial to thesubtalar joint access, by way of example under the first distal ray,would have the effect of raising the medial aspect of the orthotic andwould have the effect of causing supination and tip the foot laterallywhich would invert the subtalar joint. Attachment of the tensioningmember to the arch portion of the orthotic would draw the orthotic archheight down to be more flat. This would allow for rebound recoil springas the lever is unweighted in the back. Drawing the orthotic layer downto the platen and allowing it to rebound back up as the lever isunweighted in the back would create lift proximal to the metatarsalheads or underneath the metatarsal heads if the orthotic is lengthened.

Similarly, the orthotic could be altered in length to affect changes inthe foot anatomy. Conventional orthotics terminate behind the ball ofthe foot to allow for flexion of the ball of the foot. With thetri-layer energy return system of the present invention, the orthoticcould be lengthened to be positioned underneath the ball of the foot ifunweighting was desired at that area. Moreover, if the orthotic ispositioned underneath the metatarsal heads and supported the metatarsalhead weight a thrust upward under the ball of the foot could be createdincreasing vertical energy (as in a jump). Further, the orthotic couldalso be windowed under an area of an ulcer such that it preventedloading on the ulcer.

Those of skill in the art will appreciate that the flexibility in thebase layer 12 and the rocker bottom shape would allow normal gait whilecontrolling dorsiflexion and plantar flexion of the metatarsalphalangeal joint during gait. As noted, flexion of the base layer 12provides flex energy while also providing shock absorption.

Thus, those of skill in the art will appreciate that the attachmentpoint of the tensioning member to the orthotic and platen can be varieddepending of the type of pathology that is being treated and the lengthand position of the orthotic may also be changed to affect changes infoot anatomy, the foregoing causing the orthotic to act as a leafspring.

With the foregoing as background, FIGS. 7-10 illustrate a firstalternative embodiment of the energy return system 700 in accordancewith the invention comprising base layer 712, lever 714, platen 716 andorthotic 718. Functionally, the energy return system 700 of FIGS. 7-10performs as does the energy return system 10 of FIGS. 1-6. The energyreturn system 700 illustrated in FIG. 7 is shown at the initial contactwith the ground and is incorporated into footwear, brace or the likeshown in phantom line. Arrow depicts the normal downward force DF of thefoot and the energy return system 700 against a surface at grade. Base712 may be of any length so long as it generally extends from the soleof the foot to the toe region and may comprise any material used for thesoles of shoes including but not limited to rubber, plastics, polymers,polyurethanes and the like. Base 712 is desirably resilient functions asa leaf spring in this alternative embodiment.

Lever 714 includes slide 722, angled central portion 724, fulcrum 725,terminal portion 726 and cable 728. Lever 714 is made from a materialthat is resilient to allow it to dynamically deform during the gaitcycle. Suitable materials that may be utilized for lever 714 includeplastics, polymers and resilient metals. Orthotic 718 is also made froma material that is resilient to allow it to dynamically deform duringthe gait cycle. Suitable materials that may be utilized to constructorthotic 718 include polyolefin; polypropylene; open and closed cellfoams and graphites. Platen 716 is desirably made from rigid orsemi-rigid materials such as plastics know to those of skill in the art.

Cable 728 operably couples lever 714 at terminal portion 726 to orthotic718. Platen 716 is desirably rigid or semi rigid and is operably coupledto orthotic 718 through rear gusset 720. Platen 716 is operably coupledto base 712 by front gusset 732. Angled central portion 724 of lever 714terminates at fulcrum 713. Fulcrum 713 lies adjacent and supports platen716. Terminal portion 726 includes loop 727 that operably couples cable728 through pass 729 in platen 716. Cable 728 is coupled to orthotic 718at attachment point 731 immediately forward of the arch of the foot andthus, indirectly operably couples orthotic 718 and base 712. Cable 728is depicted as a cable or wire but may also comprise pins, rods,filaments and other structures known to those of skill in the art.

Referring now to FIG. 8, at heel strike the downward force (DF) of theheel causes base 712 to deform upwardly DU 850 toward platen 716. Slide722 moves backwards toward heel putting tension on cable 728. Cable 728thus pulls orthotic 718 away from the ball of the foot 752 causing it torise against arch 754. Referring now to FIG. 9, the foot is shown ascommencing forward rotational motion of the foot 952 toward mid-stance.Downward forces on the heel are released and unloaded 956. This reboundcauses lever 714 to move toward its original position 958, 960 releasingenergy from orthotic 718 and causing orthotic to flatten against thearch 962 and to thrust forward and upward 964.

FIG. 10 illustrates the foot continuing its normal forward rotationalmotion toward toe-off 954 with energy unloaded from the energy returnsystem.

FIGS. 11-14 illustrate a second alternative embodiment of the energyreturn system in accordance with the invention similar to FIGS. 7-10except cable 1128 is shown operably coupled to orthotic 1118 immediatelyproximal to the ball of the foot. FIGS. 11-14 again illustrate a part ofthe gait cycle from the unweighted position, to the loading response atheel strike through toe-off.

Referring now to FIG. 11, like elements are identified with likenumerals. The energy return system 1100 in accordance with the inventioncomprises base 1112, lever 1114, platen 1116 and orthotic 1118. Theenergy return system 1100 illustrated in FIG. 11 is shown prior to heelstrike and is incorporated into shoe shown in phantom line. Arrowdepicts the normal downward force DF of the foot and the energy returnsystem 1100 against a surface at grade. Base 1112 may be of any lengthso long as it generally extends from the sole of the foot to the toeregion and may comprise any material used for the soles of shoesincluding but not limited to rubber, plastics, polymers, polyurethanesand the like. Base 1112 is desirably resilient functions as a leafspring in this alternative embodiment.

Lever 1114 includes slide 1122, angled central portion 1124, fulcrum1125, terminal portion 1126 and cable 1128. Lever 1114 is made from amaterial that is resilient to allow it to dynamically deform during thegait cycle. Suitable materials that may be utilized for lever 1114include plastics, polymers and resilient metals. Orthotic 1118 may alsomade from a material that is resilient to allow it to dynamically deformduring the gait cycle. Suitable materials that may be utilized toconstruct orthotic 1118 include polyolefin; polypropylene; open andclosed cell foams and graphites. Platen 1116 is desirably made fromrigid or semi-rigid materials such as plastics known to those of skillin the art.

Cable 1128 operably couples lever 1114 at terminal portion 1126 toorthotic 1118. Platen 1116 is desirably rigid or semi rigid and isoperably coupled to orthotic 1118 through rear gusset 1120. Platen 1116is operably coupled to base 1112 by front gusset 1132. Angled centralportion 1124 of lever 1114 terminates at fulcrum 1113. Fulcrum 1113 liesadjacent and supports platen 1116. Terminal portion 1126 includes loop1127 that operably couples cable 1128 through pass 1129 in platen 1116.Cable 1128 is coupled to orthotic 1118 at attachment point 1150immediately proximal the rotation axis of the ball of the foot and thus,operably couples orthotic 1118 and platen 1116. Cable 1128 is depictedas a cable or wire but may also comprise pins, rods, filaments and otherstructures known to those of skill in the art.

Referring now to FIG. 12, downward forces at heel strike cause base 112to deform upwardly toward the heel 1250 causing lever 1114 to slideproximally 1252. As lever continues sliding proximally tension is put oncable 1128 drawing orthotic 1118 rearward 1256 away from the ball of thefoot and upward against the arch of the foot 1258.

FIG. 13 depicts the unloading 1350 of the base 1116 and the forwardunloading motion 1352, 1354 of the foot as it moves from mid-stancetoward toe-off position. The unloading motion transmits rebound energyto the system allowing lever 1114 to commence returning to originalposition. The rebound energy propels heel upward and forward whileflattening 1356 orthotic 111 against arch and to thrust forward 1357.

FIG. 14 illustrates the forward thrusting of the foot toward toe-off andthe continuing rebound due to the release of energy from the energyreturn system in accordance with the invention. Thus, the embodimentdepicted in FIGS. 11-14 is designed to address forefoot pressures andoperates with limited MPJ dorsiflexion. Thus, stress fractures,metatasalgia and foot ulcers and other types of dysfunctions may betreated.

Referring now to FIGS. 15-18 a third alternative embodiment inaccordance with the energy return system 1500 of the present inventionis illustrated. Particularly, lever 1514 is inverted and designed tooperate differently than previously described embodiments. As can beseen the attachment point 1560 of cable 1528 is at a point proximal tothe mid-arch. In addition rear gusset operably couples base 1512 withplaten 1516 and orthotic 1518. Platen 1516 is also operably coupled tobase 1512 at the forefoot by compressible tip 1517. As can be seen inFIGS. 15-16 compressible tip includes a hook 1521 that allows base 1512to uncouple due to compressive ground forces as the foot moves towardtoe-off and recouple when no compressive forces are present. FIG. 15depicts the energy return system in the unburdened profile or in otherwords at rest. Referring to FIG. 16, downward force DF createssystematic collection of potential energy by compressing resilient leafspring-like base 1512. Angled central portion 1524 of lever 1514 rotatesforward as cable 1528 pulls orthotic 1518 downward D away from arch. Theflattening of orthotic 1528 presses the distal edge of orthotic forwardand compressible tip 1517 bulges forward. As best seen in FIG. 17 as thefoot nears toe-off, energy is further absorbed as base 1512 continues toflatten and rotates lever 1514 to continue drawing orthotic 1518 toflatten while the distal edge of orthotic moves forward and the ball offoot begins to lift. As best seen in FIG. 18, as the foot is raised androtated forward F toward toe-off the base 1512 and flattened orthotic1518 release stored energy causing angled central portion 1524 of lever1514 to move rearward which releases the tension on cable 1528 andorthotic 1518. Orthotic 1518 returns or rebounds to support the arch offoot.

The embodiment depicted in FIGS. 15-18 is designed for the treatment ofequines (toe runners with no heel strike) in which limited dorsiflexionat the ankle causes pathology. Equines is the primary cause of ulcers indiabetic equines patients.

FIG. 19 depicts a fourth alternative embodiment 2010 of the energyreturn system with the foot depicted in a static unburdened position.Like elements are labeled with like numerals. Particularly, orthotic2018 is attached to platen 2016 at the rear of the foot 2020. Base 2012is attached to platen 2016 underneath the ball of the foot 2029. Band2011 surrounds the phalanges and the cable 2028 is attached to the band.As platen 2016 flattens, lever 2014 functions to drawn arch up U.Orthotic 2018 moves rearward R and upward U against the arch whendownward force is applied to the ground during the gait cycle. Thisembodiment is designed to treat plantar fascia.

FIGS. 20 and 21 depict a fifth alternative embodiment 2110 of the energyreturn system in accordance with the invention designed to treat plantarfasciitis. Like elements are labeled with like numerals. Base 2112 isattached to platen 2116 behind heel at 2120. As best seen in FIG. 21,orthotic 2118 is modified to form a cup that cradles sulcus 2119 thusallowing the foot to roll forward during gait without restriction. Cable2128 is coupled to orthotic 2118 slightly forward of sulcus 2019. Base2112 and platen 2116 are coupled underneath the ball of the foot 2129through to tip 2131. Lever 2114 will thus draw the orthotic 2118rearward R and upward U against the arch and draws the sulcus rearwardwhen downward force is applied to the ground during the gait cycle.

FIG. 22 depicts a sixth alternative embodiment of the invention. Theorthotic is fixedly attached at the distal end to platen 2260 and freeat the proximal end. As can be seen, orthotic is cupped around heel. Thebase layer 2212 is fixedly attached 2215 at the proximal end to platen2216. Cable 2228 is attached to orthotic 2218 underneath the sole of thefoot. In this embodiment as the user propels through the gait cycle, theorthotic 2218 will be drawn forward 2223 while lifting 2225 beneath thearch giving support to the plantar fascia.

FIG. 23 depicts a seventh alternative embodiment of the energy returnsystem in accordance with the invention. Like features have likenumerals. As can be seen, orthotic 2318 is fixedly attached 2360 at thedistal end to platen 2316. Orthotic 2318 is cupped around the heel ofthe foot. The proximal end of orthotic 2318 is free. Base 2312 isfixedly attached to platen 2316 by spacer or bridge 2315, whichmitigates ground reactive forces. Cable 2328 is attached to orthoticslightly forward of the heel. In operation, as the foot moves throughthe gait cycle, the orthotic 2318 is drawn forward 2223 while liftingthe arch upward 2225 giving support to the plantar fascia.

As discussed previously, in human anatomy, the subtalar joint occurs atthe meeting point of the talus and the calcaneus. The subtalar jointallows inversion and eversion of the foot during the gait cycle. Thus,depending on the particular foot pathology needing treatment, theattachment point of the tensioning member would affect the function ofthe energy return system.

Tensioning member is attached to the orthotic underneath the archportion. Thus the tensioning member would draw the orthotic arch heightdown to be more flat. This would allow for rebound recoil spring as thelever is unweighted in the back. Drawing the orthotic layer down to theplaten and allowing it to rebound back up as the lever is unweighted inthe back would create lift proximal to the metatarsal heads orunderneath the metatarsal heads. Referring now to FIGS. 24-26 attachmentpoint 2412 of tensioning member is underneath the arch portion of theorthotic 2418. As can best be seen in FIG. 25, the tensioning member isflattening orthotic 2418 downwardly 2415 thus creating lift proximal tothe metatarsal heads or underneath the metatarsal heads.

Referring now to FIGS. 27-28 orthotic 2400 is depicted with a segment orcut 2401 on the lateral side of orthotic 2400. Attachment point 2412 oftensioning member 2428 is medial to the subtalar joint access, distallyunder the first ray. In operation, the tensioning member 2128 causesorthotic 2400 to rotate downward 2414 on the medial side of the orthoticby therapeutic angle 2416 increasing forefoot varus dynamically havingthe effect of raising the medial aspect of the orthotic arch and wouldhave the effect of causing supination and tip the foot laterally whichwould invert the subtalar joint.

If the attachment point of the tensioning member is placed lateral tothe subtalar joint access toward the fifth ray or the lateral aspect ofthe foot, it would have the effect of raising the lateral aspect of theorthotic arch to pronate the foot or tip the foot inward and causeeversion of the subtalar joint. FIGS. 29-30 illustrate orthotic 2900with segment or cut 2901 on the lateral side of the orthotic 2900 andtensioning member 2428. Tensioning member 2428 is attached to orthotic2900 laterally at attachment point 2912. In this position, tensioningmember 2428 causes orthotic 2900 to rotate downward on the lateral sideby therapeutic angle 2916 increasing forefoot valgus dynamically havingthe effect of causing pronation and tipping the foot medially.

Referring now to FIG. 31-32 an orthotic 3100 with a segmented digitarray 3112 is depicted. The orthotic includes a tension attachment point3114 on a selected digit array. In operation the selected digit 3112 oforthotic 3100 is pulled downward 3116 by therapeutic angle 3118 toachieve the remedial therapeutic goal of dynamic offloading of themetatarsals. For example, if the attachment point is on the firstsegmented ray dynamic offloading of the first metatarsal-phalangealjoint occurs to treat Hallux Limitus. If the attachment point is on thesecond ray stress fractures, matasalgia and the like are treated. Thoseof skill in the art will appreciate that the attachment point of thetensioning member may be attached to any ray of the segmented orthoticto result in dynamic off-loading of a particular metatarsal.

Those of skill in the art will appreciate that the segmented orthoticdescribed herein in not limited as to which how the orthotic issegmented or which ray the tensioning member is attached to. Ratherdepending on the particular foot pathology that needs correction anysegment or the orthotic can be made and the tensioning member may beattached to any ray. For example, it is anticipated that two parallelcuts could be made in the orthotic while the tensioning member isattached to the second ray making the second ray dynamic.

FIGS. 34-41 depict a bi-layer orthotic in accordance with the inventionwith a cushioning layer between orthotic 3400 and base layer 3412omitted for clarity. FIG. 34 is a side elevational view of a bi-layerorthotic 3400 in accordance with an embodiment of the invention. As canbe seen base layer 3412 is operably coupled to orthotic at the heel ofthe orthotic by off axis rotator axel 3420. Off axis rotator axel 3412is pivotally received by base layer 3412 and orthotic 3418 so thatorthotic 3418 pivots relative to the base 3412.

FIG. 35 is a rear elevational view taken along line 35-35 of FIG. 34showing a pronated foot requiring correction. FIG. 36 is a rearelevational view of the pronated foot received within the heel cup oforthotic 3418. As seen the orthotic heel cup pivots to provide thetherapeutic correction to the pronated foot.

Similarly, FIG. 37 is a dynamic rear elevational view similar to that ofFIG. 36 showing a supinated foot that required correction and showingthe correction as the foot is received by the orthotic heel cup and theheel cup pivots to correct the supinated foot during the gait cycle.

FIG. 38 is a side elevational view of a first alternative bi-layerorthotic embodiment in accordance with the invention again with acushioning layer between the orthotic 318 and base layer 3812 omittedfor clarity. Bi-layer orthotic 3800 includes base layer 3812 andorthotic 3818. Orthotic 3818 is coupled to base layer 3812 by arcuaterotator follower 3420 as best seen in the enlarged view depicted in FIG.38A. As best seen in FIGS. 39-41 arcuate rotator follower 3420 travelsin channel 3924, 3925. Channel 3924, 3925 is curved in the bi-layerorthotic to the right or left depending on the required correction, i.e.pronation or supination.

FIG. 39 is a rear elevational view taken along line 39-39 in FIG. 38with the addition of the lower portion of a leg and supinated footrequiring correction. FIG. 40 is a rear elevational view thereof showingthe therapeutic correction using the bi-layer orthotic in accordancewith the invention. FIG. 41 is a dynamic rear elevational view similarto that of FIG. 36 with a pronated foot that required correction showingthe correction. As can be seen in each of these FIGS. arcuate rotatorfollower 3420 travels in channel 3924, 3925 to the right or leftdepending on the required correction.

FIG. 42 is a rear elevational view of a second alternative embodiment ofa bi-layer orthotic similar to that shown in FIG. 38 but including twoarcuate channels and showing a pronated foot descending downward intothe orthotic. FIG. 43 is a view similar to that of FIG. 42 showing thecorrection of the pronated foot. FIG. 44 is similar to the embodiment ofFIGS. 42 and 43 wherein a supinated foot is shown descending and thenhaving been corrected by the bi-layer orthotic of FIG. 42 in accordancewith the invention.

FIG. 45 is a side elevational view of a third alternative embodiment ofa bi-layer orthotic in accordance with the invention with cushioninglayer omitted for clarity and especially designed for women's footwear.FIG. 46 is a rear elevational view thereof. FIG. 47 is a frontelevational view thereof. FIG. 48 is a bottom plan view thereof FIG. 49is a bottom plan view of a first alternative embodiment of the bi-layerorthotic of FIGS. 45-48 in accordance with the invention. FIG. 50 is abottom plan view of a second alternative embodiment of the bi-layerorthotic of FIGS. 45-48 in accordance with the invention. FIG. 51 is abottom plan view of a third alternative embodiment of the bi-layerorthotic of FIGS. 45-48. FIG. 52 is a bottom plan view of a fourthalternative embodiment thereof.

FIG. 53 is a top plan view of an alternative embodiment of an orthoticin accordance with the invention showing kick stand 5300. The kick stand5300 is pivotally coupled to orthotic 5316 at heel 5317. Medial movementof the kick stand allows pronation of foot to be corrected. When kickstand 5300 is deployed the foot moves laterally, as best seen, in FIG.54 due to the decrease in forefoot abduction. Compressibility of thebilayer orthotic allows patient tolerability of dynamic control due toshock absorption. Those of skill in the art will appreciate that thekick stand 5300 could be placed on the lateral side of the orthotic tocorrect pronation.

Turning now to FIGS. 55-56 an alternative embodiment of the bi-layerorthotic in accordance with the invention is shown. Bi-layer orthotic5500 broadly includes dynamic base layer 5512, orthotic 5514 and boot5516. As can be seen base layer 5512 is operably coupled to orthotic5514 at the heel 5518 of the orthotic by off axis rotator axel 5420. Offaxis rotator axel 5520 is pivotally received by base layer 5512 andorthotic 5514 so that orthotic 5514 pivots relative to the base 5512.Dynamic base layer 5512 includes upright supports 5522 operablyconnected at a first end 5523 thereto. Upright supports 5522 includecutouts 5524 for malleoli (ankle bones). Upright supports 5522 includeoptional hinge pin 5527 that operably couples upright support 5522 toboot 5516. Hinge pin 5527 allows for articulation if ankle range ofmotion is desired. Upright supports 5522 terminate at a second end 5525with pull tab 5526.

Pull tab 5526 is fixedly coupled to boot 5516 and includes fingerportion 5528 that allow a user to pull on it to facilitate easy donningof the boot 5516. Boot 5516 may optionally include straps 5530. Straps5530 act to limit anterior/posterior displacement of the foot relativeto the upright supports 5522 and are positioned such that they do notencircle the ankle or lower leg thus avoiding constriction and/orirritation of that anatomy. FIG. 56 depicts a second pull tab 5600 thatmay be positioned within an upper edge of boot 5516 to facilitatedonning of the boot. Second pull tab 5600 may include a neoprene likepadded collar to accommodate edema and changes in leg size.

Those of skill in the art will appreciate that the disclosed embodimentsin accordance with the invention are designed to accommodate numerousmodifications as hereinbefore described. Thus, although the presentinvention has been described with reference to certain embodiments,those of ordinary skill in the art will recognize that changes may bemade in form and detail without departing from the spirit and scope ofthe invention.

I claim:
 1. A bi-layer orthotic comprising: an orthotic having a heelportion and a front portion; a coupling; a base layer coupled to saidorthotic at the heel portion by said coupling, wherein said coupling isstructured to allow said heel portion to pivot relative to the base. 2.The bi-layer orthotic of claim 1 wherein said pivotal coupling comprisesan off axis rotator axel.
 3. The bi-layer orthotic of claim 1 furthercomprising a cushioning layer positioned between said base layer andsaid orthotic.
 4. The bi-layer orthotic of claim 1 wherein said heelportion is configured to receive a heel of a pronated or supinated footrequiring therapeutic correction.
 5. The bi-layer orthotic of claim 1wherein said pivotal coupling comprises an arcuate rotator follower. 6.The bi-layer orthotic of claim 5 wherein said base layer includes achannel for receiving said arcuate rotator follower.
 7. The bi-layerorthotic of claim 6 wherein said channel for receiving said arcuaterotator follower curves to the left and is configured to provide atherapeutic correction to a supinated foot.
 8. The bi-layer orthotic ofclaim 6 wherein said channel for receiving said arcuate rotator followercurves to the right and is configured to provide a therapeuticcorrection to a pronated foot.
 9. The bi-layer orthotic of claim 5wherein said base layer includes a plurality of channels for receivingsaid arcuate rotator follower.
 10. The bi-layer orthotic of claim 9wherein said plurality of channels for receiving said arcuate rotatorfollower curve to the left and are configured to provide a therapeuticcorrection to a supinated foot.
 11. The bi-layer orthotic of claim 9wherein said plurality of channels for receiving said arcuate rotatorfollower curve to the right and are configured to provide a therapeuticcorrection to a pronated foot.
 12. The bi-layer orthotic of claim 1wherein said orthotic is incorporated into a shoe.
 13. The bi-layerorthotic of claim 1 wherein said base layer comprises a resilientmaterial.
 14. The bi-layer orthotic of claim 1 further comprising aboot, said boot coupled to said orthotic and said base layer by saidcoupling.
 15. The bi-layer orthotic of claim 14 further comprising atleast one upright support having first and second ends, said first endoperably coupled to said base layer, said upright support including acut out structured for accommodating a malleoli.
 16. The bi-layerorthotic of claim 15 further comprising at least one hinge pin foroperably coupling said upright support to said boot.
 17. The bi-layerorthotic of claim 15 wherein said at least one upright support includesa pull tab fixedly coupled to said boot.
 18. The bi-layer orthotic ofclaim 17 wherein said pull tab includes a finger portion configured toaccommodate a user's finger to facilitate donning of said boot.
 19. Thebi-layer orthotic of claim 14 wherein said boot further includes one ormore straps structure to limit anterior and/or posterior displacement ofa user's foot relative to said upright support.
 20. The bi-layerorthotic of claim 19 wherein said boot straps are structured to limitconstriction of a user's ankle or lower leg.
 21. The bi-layer orthoticof claim 18 further comprising a second pull tab positioned within anupper edge of said boot.
 22. The bi-layer orthotic of claim 21 whereinsaid second pull tab a padded collar.
 23. The bi-layer orthotic of claim22 wherein said padded collar comprises neoprene.